Official deadlines may be compromising drug safety

Washington, March 27 (IANS) Drugs fast-tracked by the US Food and Drug Administration (FDA) are more likely to be withdrawn from global markets for safety reasons, undergo manufacturing revisions, or face labelling changes, according to a study. “Drugs rushed for approval just before deadline are two times more likely to be pulled off shelves due to safety concerns, two to seven times more likely to receive added label warnings and two to seven times more likely to be discontinued because of weak clinical demand,” said Daniel Carpenter of Harvard University, co-author of the study.

“Because of similarly high-profile regulatory mistakes in recent years, we will likely see greater congressional scrutiny in coming decades as these FDA deadlines come up for renewal every five years,” Carpenter said.

Fifty years ago, the FDA approved most new medications within a few months of receiving applications from manufacturers. Over time, the process slowed as new review protocols were added in the wake of pharmaceutical missteps such as thalidomide, which led to the births of thousands of deformed babies in the late 1950s and early 1960s.

The deadlines imposed on the FDA’s drug-approval process were first enacted as part of the Prescription Drug User Fee Act (PDUFA) of 1992, which mandated that the FDA must act on 90 percent of all drug candidates within 12 months of submission or face funding cuts.

The timeline was tightened to 10 months as part of the 1997 Food and Drug Administration Modernization Act, a timeline extended by Congress in 2002 as part of bio-terrorism legislation and renewed again in 2007.

In previous work, Carpenter developed a mathematical model to understand how government agencies “learn” and how deadlines affect organisational behaviour.

The study has been published in the latest issue of the New England Journal of Medicine.